unit 4

Question 1

What is pharmaceutical formulation

Answer 1

• Formation of pharmaceutical product
• Formulation development outlines the key aspects of API excipients,
• Associated interactions
• Manufacturing Procedures

Question 2

What does the quality of medicinal products involve

Answer 2

• facility and equipment
• validation
• training
• documentation
• auditing
• testing
• specifications

Question 3

How can pharmaceutical industry mplement sustainable practices in order to minimize its environmental footprint.

Answer 3

-reduce greenhouse gas emissions
-conserve natural resources
- address the increasing concerns about climate change.

Question 4

What is a dosage form

Answer 4

• physical form of a drug such as a solid, liquid or gas.
• Common dosage forms include tablets, capsules, semisolids, solutions, injections and aerosols.

Question 5

What are types of solid dosage forms

Answer 5

• tablet, capsules, chewing gum , pellets, films

Question 6

Merits of solid dosage forms

Answer 6

dose accuracy, stability of the drug, easy to pack and handle, portability, reproducibility.

Question 7

Demerits of solid dosage forms

Answer 7

• Not suitable for unconcsious patients.
• Formulation complications

Question 8

What are types of liquid dosage forms - monophasic.

Answer 8

solutions, elixir, syrups

Question 9

Merits of liquid dosage forms - monophasic.

Answer 9

easy to swallow and manufacture
fast absorption

Question 10

Demerits of liquid dosage forms - monophasic.

Answer 10

non uniformity of dosage
prone to microbial attack

Question 11

Liquid dosage forms biphasic.

Answer 11

suspensions
emulsions

Question 12

Merits of Liquid dosage forms biphasic

Answer 12

less processing steps
less excipients required comapred to tablets.

Question 13

Demerits of Liquid dosage forms biphasic.

Answer 13

less stability
unsuitable, unpleaseant taste and obnoxious drugs

Question 14

Semisolid dosage forms

Answer 14

creams, gels, liniment, lotion, ointment

Question 15

Merits of semiisolid dosage forms

Answer 15

-easy to use
-more stable than liquid dosage form
-local action of drug on affected area
- patient convenience easy to apply& remove

Question 16

Demerits of semisolid dosage forms

Answer 16

• difficult to handle
• chance of contamination
• may cause staining, irration
• more prone to environment effect

Question 17

Merits of Gaseous dosage forms

Answer 17

• easy to handle, convenient
• withdrawal of dose without contamination
• provides medication to local area
• tamper proof

Question 18

Demerits of gaseous dosage forms

Answer 18

• expensive
• limited safety
• may cause environmental hazards

Question 19

What is the overall aim of dosage form design

Answer 19

increase the stability of the drug substances to extend its shelf life, ensure accurate dosing and deliver the drug in suitable form.

Question 19

Chemical properties of dosage form

Answer 19

structure, form, and reactivity

Question 20

Physical properties of dosage form

Answer 20

physical description,
particle size,
particle shape,
flowability,
powder density,
crystalline structure,
melting point,
solubility

Question 21

Chemical analysis in preformulation

Answer 21

identification of drug molecule - UV -Vis. IR, DSC
Assay - HPLC, TLC

Question 22

Physiochemical properties

Answer 22

solubility, pH, log P, pKa, dissolution

Question 23

method/analysis of Physiochemical properties

Answer 23

salt forms, co-solvent, complexation, pro - drug.

Question 24

Pharmaceuitical analysis

Answer 24

Solid state stability - temp, humidity, light
Chemical compatibility - processing
Biopharmaceutical properties - ADME

Question 25

Physical analysis

Answer 25

Hygroscopicity - Karl fisher, Gas chromotography, TGA
Melting point - DSC- polymorphism, hydrate & solvent.
Microscopy - particle shape and size

Question 26

Dosage forms development

Answer 26

dosage forms development is a complex process that involves the integration of multiple disciplines. The goal of this process is to create a safe and effective drug product that meets the needs of the patient.

Question 27

process

Answer 27

• involves combining different inactive substances with the active pharmaceutical ingredient (API) to produce an end- product for patients.
• Pharmaceutical excipients are classified according to function they performed.
• Once the formulation and dosage form have been developed
• conduct preclinical and clinical studies to evaluate the safety and efficacy of the drug product.
• This includes conducting animal studies to evaluate the pharmacokinetics and pharmacodynamics of the drug product, as well as conducting human studies to evaluate the safety and efficacy of the drug product in humans.
• the drug product must be manufactured in accordance with good manufacturing practices
• ensuring that the drug product is manufactured in a clean and sterile environment, and that the drug product meets all regulatory requirements.